Cleared Traditional

K932346 - AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS

K932346 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 238-day FDA review.

K932346 · Aesculap, Inc. · General & Plastic Surgery device
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Jan 1994
Decision
238d
Days
Class 2
Risk

K932346 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 January 7, 1994 after a review of 238 days - an extended review 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: 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 Aesculap, Inc. devices

Submission Details

510(k) Number K932346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1993
Decision Date January 07, 1994
Days to Decision 238 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
123d slower than avg
Panel avg: 115d · This submission: 238d
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 K932346.
STERILE, DISPOSABLE ENDO SPECIEMEN RETRIEVAL BAG
K934165 · Phx Technologies Corp. · Jan 1994
PHX TECHNOLOGIES CORP., 5MM, 10MM, AND 12MM BLUNT-TIPPED TROCAR OBTURATORS AND MATCHED TROCAR TUBES
K934279 · Phx Technologies Corp. · Jan 1994
PHX TECHNOLOGIES CORP., 10 MM THORACOSCOPY SCRAPPER DEVICE
K934280 · Phx Technologies Corp. · Jan 1994
10MM DISPOSABLE, STERILE SUCTION CANNULA
K933789 · Phx Technologies Corp. · Jan 1994
5MM DISPOSABLE SUCTION-IRRIGATION CANNULA
K933790 · Phx Technologies Corp. · Jan 1994
PHX TECHNOLOGIES CORP., GRASPER-RETRACTOR DEVICE
K933895 · Phx Technologies Corp. · Dec 1993