Cleared Traditional

K933076 - AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS

K933076 is the FDA 510(k) clearance for AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS by Aesculap, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K933076 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
79d
Days
Class 2
Risk

K933076 is an FDA 510(k) clearance for the AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on September 10, 1993 after a review of 79 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 Aesculap, Inc. devices

Submission Details

510(k) Number K933076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1993
Decision Date September 10, 1993
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 677
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K933076.
AUTO SUTURE ENDOSCOPIC INSTRUMENT CLAMP
K932885 · United States Surgical, A Division of Tyco Healthc · Sep 1993
SURGICAL TROCAR AND CANNULA
K932995 · Applied Medical Resources · Sep 1993
ONE-HANDED ENDOPOUCH SPECIMEN RETRIEVAL BAG
K933104 · Ethicon, Inc. · Sep 1993
RETRACTION INSTRUMENT
K921103 · Origin Medsystems, Inc. · Sep 1993
ENDOSCOPE ACCESSORY
K931895 · Applied Medical Resources · Sep 1993
CABOT MEDICAL OPTIMA HAND INSTRUMENTS
K932976 · Cabot Medical Corp. · Sep 1993