Medical Device Manufacturer · US , Devers , MA

Microline Pentax, Inc.

12 submissions · 12 cleared · Since 1988
12
Total
12
Cleared
0
Denied

Microline Pentax, Inc. — FDA 510(k) Submissions

Microline Pentax, Inc. has submitted 12 FDA 510(k) premarket notifications since 1988, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrosurgical, Cutting & Coagulation & Accessories, Laparoscope, General & Plastic Surgery, Instrument, Vitreous Aspiration And Cutting, Ac-powered, Forceps, Ophthalmic, Scissors, Ophthalmic . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10
K013695 · GCJ Laparoscope, General &... · General & Plastic Surgery
Jan 2002 62d
ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS
K982984 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 1998 56d
DISPOSABLE RE-NEW FORCEPS
K981389 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 1998 43d
ELECTROSURGICAL CAUTERY PROBES
K981188 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 1998 48d
3 MM SELEC-TIP LAPAROSCOPIC SCISSORS
K980758 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Mar 1998 28d
RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS
K974066 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jan 1998 87d
SELECTA-TIP LAPAROSCOPIC SCISSORS
K970826 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Mar 1997 22d
RE-NEW LAPAROSCOPIC INSTRUMENTS
K962119 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Aug 1996 70d
QUICK SWITCH LAPAROSCOPIC INSTRUMENTS
K932648 · GCJ Laparoscope, General &... · General & Plastic Surgery
Oct 1993 132d
INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA.
K897093 · HNF Scissors, Ophthalmic · Ophthalmic
Apr 1990 105d
BRADBURY INTRAOCULAR RETINAL KIT CAT #200
K881049 · HNR Forceps, Ophthalmic · Ophthalmic
Sep 1988 185d
MICROLINE CAT #100
K880943 · HQE Instrument, Vitreous... · Ophthalmic
May 1988 80d
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