Cleared Traditional

K942730 - AESCULAP LAPAROSCOPES

K942730 is the FDA 510(k) clearance for AESCULAP LAPAROSCOPES by Aesculap, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 320-day FDA review.

K942730 · Aesculap, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Apr 1995
Decision
320d
Days
Class 2
Risk

K942730 is an FDA 510(k) clearance for the AESCULAP LAPAROSCOPES. 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 April 25, 1995 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K942730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1994
Decision Date April 25, 1995
Days to Decision 320 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
160d slower than avg
Panel avg: 160d · This submission: 320d
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 K942730.
KSE STEINER ELECTROMECHANIC MORCELLATOR
K946147 · KARL STORZ Endoscopy-America, Inc. · May 1995
KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS
K946359 · KARL STORZ Endoscopy-America, Inc. · May 1995
KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS
K945685 · KARL STORZ Endoscopy-America, Inc. · May 1995
KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE
K945211 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
AESCULAP LAPAROSCOPIC ANCILLARY DEVICES
K943603 · Aesculap, Inc. · Mar 1995
KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER
K945982 · KARL STORZ Endoscopy-America, Inc. · Mar 1995