Cleared Traditional

K912933 - MEDICAM LAPAROSCOPY ENDOSCOPES

K912933 is an FDA 510(k) clearance for MEDICAM LAPAROSCOPY ENDOSCOPES, manufactured by Kirschner Medical Corp.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K912933 · Kirschner Medical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
102d
Days
Class 2
Risk

K912933 is an FDA 510(k) clearance for the MEDICAM LAPAROSCOPY ENDOSCOPES. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on October 15, 1991 after a review of 102 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Kirschner Medical Corp. devices

FDA 510(k) Submission Details - K912933

510(k) Number K912933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1991
Decision Date October 15, 1991
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 115d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 723
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K912933.
TROCAR
K914377 · O.R. Concepts, Inc. · Oct 1991
MONOSCOPY(TM) BRAND, ENDOBAG
K913762 · Dexide, Inc. · Oct 1991
EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE
K912492 · Ethicon, Inc. · Oct 1991
LAPAROSCOPIC BALLOON RETRACTOR
K914203 · Origin Medsystems, Inc. · Oct 1991
GRASPER, RATCHETED (5MM X 30CM)
K913991 · Northgate Technologies, Inc. · Oct 1991
ENDOPATH DISPOSABLE ENDOSCOPIC MULTIFEED STAPLER
K913469 · Ethicon, Inc. · Sep 1991