Cleared Traditional

K944467 - AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS

K944467 is an FDA 510(k) clearance for AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS, manufactured by Aesculap, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K944467 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
24d
Days
Class 2
Risk

K944467 is an FDA 510(k) clearance for the AESCULAP MANUAL LAPAROSCOPIC 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 October 3, 1994 after a review of 24 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.

FDA 510(k) Submission Details - K944467

510(k) Number K944467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1994
Decision Date October 03, 1994
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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 1431
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K944467.
UNIGRIP
K943502 · Unisurge, Inc. · Oct 1994
GSI KNOTMAKER
K944536 · General Surgical Innovations · Oct 1994
MSV-2000 VIDEO IMAGING SYSTEM
K942924 · Del Medical Systems Corp. · Oct 1994
GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER
K942574 · Acufex Microsurgical, Inc. · Sep 1994
CARRIER, LIGATURE (79 GEJ)
K944465 · Endotec, Inc. · Sep 1994
SINGLE STICK RADIALLY EXPANDING DILATOR
K943056 · Innerdyne Medical, Inc. · Sep 1994
K944467 · AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS
Download PDF FDA Summary Aesculap, Inc.