Cleared Traditional

K943603 - AESCULAP LAPAROSCOPIC ANCILLARY DEVICES

K943603 is the FDA 510(k) clearance for AESCULAP LAPAROSCOPIC ANCILLARY DEVICES by Aesculap, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K943603 · Aesculap, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
247d
Days
Class 2
Risk

K943603 is an FDA 510(k) clearance for the AESCULAP LAPAROSCOPIC ANCILLARY DEVICES. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on March 29, 1995 after a review of 247 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Aesculap, Inc. devices

Submission Details

510(k) Number K943603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1994
Decision Date March 29, 1995
Days to Decision 247 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 160d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 150
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K943603.
KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS
K945685 · KARL STORZ Endoscopy-America, Inc. · May 1995
AESCULAP LAPAROSCOPES
K942730 · Aesculap, Inc. · Apr 1995
KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE
K945211 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER
K945982 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
LAPAROSCOPE AND ACCESSORIES FOR OB/GYN
K950232 · Olympus America, Inc. · Mar 1995
CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020
K932276 · KARL STORZ Endoscopy-America, Inc. · Feb 1995