Medical Device Manufacturer · US , Tustin , CA

Surgin Surgical Instrumentation, Inc.

23 submissions · 23 cleared · Since 1993
23
Total
23
Cleared
0
Denied

Surgin Surgical Instrumentation, Inc. — FDA 510(k) Submissions

Surgin Surgical Instrumentation, Inc. has submitted 23 FDA 510(k) premarket notifications since 1993, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Unit, Phacofragmentation, Keratome, Ac-powered, Laparoscope, General & Plastic Surgery, Electrosurgical, Cutting & Coagulation & Accessories, Tubing, Replacement, Phacofragmentation Unit . Use the specialty filter in the sidebar to narrow results.

23 devices
1–23 of 23
DUAL SYRINGE HOLDER
K082110 · FMG Stopcock, I.v. Set · General Hospital
Jun 2009 324d
PRIZM KERATOME BLADE, MODEL MK8512M2
K033236 · HNO Keratome, Ac-powered · Ophthalmic
Mar 2004 172d
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
K033182 · HNO Keratome, Ac-powered · Ophthalmic
Jan 2004 121d
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
K011195 · HNO Keratome, Ac-powered · Ophthalmic
Nov 2001 201d
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
K994015 · HNO Keratome, Ac-powered · Ophthalmic
Mar 2000 110d
SURGIN KIT
K980849 · MSR Tubing, Replacement,... · Ophthalmic
Jul 1998 154d
SURGIN GENISIS HANDPIECE
K954238 · HQC Unit, Phacofragmentation · Ophthalmic
Dec 1995 88d
VACUUM SURGE SUPRESSER
K950600 · HQC Unit, Phacofragmentation · Ophthalmic
May 1995 90d
CASSETTE SYSTEM FOR STORZ
K942945 · HQC Unit, Phacofragmentation · Ophthalmic
Dec 1994 166d
IRRIGATION/BIPOLAR SET
K942944 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Sep 1994 97d
OPTHALMIC WIPE
K942897 · HQZ Frame, Spectacle · Ophthalmic
Aug 1994 46d
SURGICAL LIFT SHEET
K942807 · FSA Lift, Patient,... · General Hospital
Aug 1994 49d
HIGH PERFORMANCE TIPS
K943102 · HQC Unit, Phacofragmentation · Ophthalmic
Jul 1994 29d
PHACO KIT
K942515 · HQC Unit, Phacofragmentation · Ophthalmic
Jul 1994 60d
10-0 CASSETTE
K942516 · HQC Unit, Phacofragmentation · Ophthalmic
Jul 1994 60d
10-K CASSETTE
K942517 · HQC Unit, Phacofragmentation · Ophthalmic
Jul 1994 60d
CASSETTE SYSTEM FOR SITE
K942518 · HQC Unit, Phacofragmentation · Ophthalmic
Jul 1994 60d
REUSABLE PROBES
K943070 · GCJ Laparoscope, General &... · General & Plastic Surgery
Jul 1994 24d
CLAMPS AND CLIPS
K942896 · MDM Instrument, Manual,... · General & Plastic Surgery
Jul 1994 29d
SURGI-WIPE
K942642 · HOZ Sponge, Ophthalmic · Ophthalmic
Jul 1994 42d
SURGIN IRRIGATION PUMP
K942641 · GCJ Laparoscope, General &... · General & Plastic Surgery
Jul 1994 34d
FLUID ASPIRATION NEEDLE
K935293 · GCJ Laparoscope, General &... · General & Plastic Surgery
Feb 1994 104d
SUTURE HANDLER
K934173 · GCJ Laparoscope, General &... · General & Plastic Surgery
Dec 1993 97d
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