Medical Device Manufacturer · US , Bloomfield , IN

Mectra Labs, Inc.

9 submissions · 9 cleared · Since 1992
9
Total
9
Cleared
0
Denied

Mectra Labs, Inc. — FDA 510(k) Submissions

Mectra Labs, Inc. has submitted 9 FDA 510(k) premarket notifications since 1992, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Insufflator, Laparoscopic, Laparoscope, General & Plastic Surgery, Electrosurgical, Cutting & Coagulation & Accessories, Coagulator-cutter, Endoscopic, Bipolar (and Accessories), Anti Fog Solution And Accessories, Endoscopy . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
TUBALGATOR
K113080 · HIN Coagulator-cutter,... · Obstetrics & Gynecology
Jun 2012 255d
ELECTRO-LUBE
K033880 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Mar 2004 86d
PNEUMOPERITONEUM INSUFFLATION NEEDLE
K021247 · HIF Insufflator, Laparoscopic · Obstetrics & Gynecology
Nov 2002 203d
ENDOSCOPIC ANTI FOG DEVICE
K993604 · OCT Anti Fog Solution And... · Gastroenterology & Urology
Mar 2000 130d
SUCTION CAUTERY PROBE
K955352 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 1996 136d
MECTRA TROCAR
K934547 · GCJ Laparoscope, General &... · General & Plastic Surgery
Feb 1994 149d
GRASPERS
K935382 · GCJ Laparoscope, General &... · General & Plastic Surgery
Feb 1994 99d
INSUFFLATION TUBING
K925691 · HIF Insufflator, Laparoscopic · Obstetrics & Gynecology
Sep 1993 315d
INSUFFLATOR, LAPAROSCOPIC
K920959 · HIF Insufflator, Laparoscopic · Obstetrics & Gynecology
Jul 1992 139d
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