Cleared Traditional

K962799 - MINIATURE LAPAROSCOPE SET (MINI LAP)

K962799 is an FDA 510(k) clearance for MINIATURE LAPAROSCOPE SET (MINI LAP), manufactured by Richard Wolf GmbH. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K962799 · Richard Wolf GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
85d
Days
Class 2
Risk

K962799 is an FDA 510(k) clearance for the MINIATURE LAPAROSCOPE SET (MINI LAP). Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Richard Wolf GmbH (Knittlingen, Baden-Wurttemberg, DE). The FDA issued a Cleared decision on October 11, 1996 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Richard Wolf GmbH devices

FDA 510(k) Submission Details - K962799

510(k) Number K962799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1996
Decision Date October 11, 1996
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
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 1066
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K962799.
ENDOCAM
K963046 · Corin USA · Nov 1996
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S-357 VIDEO IMAGING SYSTEM
K962684 · Del Medical Systems Corp. · Oct 1996
HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2
K961463 · Heartport, Inc. · Oct 1996
ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR
K960301 · Del Medical Systems Corp. · Sep 1996
S-52 ELECTRONIC VIDEO LAPAROSCOPE
K962651 · Del Medical Systems Corp. · Sep 1996