Cleared Traditional

K955412 - A.S.D. SAFETY TROCAR

K955412 is an FDA 510(k) clearance for A.S.D. SAFETY TROCAR, manufactured by American Surgical Devices. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K955412 · American Surgical Devices · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
169d
Days
Class 2
Risk

K955412 is an FDA 510(k) clearance for the A.S.D. SAFETY TROCAR. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by American Surgical Devices (Fremont, US). The FDA issued a Cleared decision on May 14, 1996 after a review of 169 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 American Surgical Devices devices

FDA 510(k) Submission Details - K955412

510(k) Number K955412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1995
Decision Date May 14, 1996
Days to Decision 169 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
9d slower than avg
Panel avg: 160d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

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 225
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K955412.
SAFETY TROCER WITH SPRINGLOADED OBDURATOR
K960347 · Spiess Design, Inc. · Jul 1996
SHIELDED TROCAR (OBTURATOR)
K954774 · Gabris Surgical Corp. · Jun 1996
KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY
K950335 · KARL STORZ Endoscopy-America, Inc. · May 1996
FLO-STAT FLUID MONITORING SYSTEM
K954775 · Gynecare Innovation Center · May 1996
CORING MORCELLATOR
K960262 · Cook Urological, Inc. · Apr 1996
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES
K951343 · KARL STORZ Endoscopy-America, Inc. · Apr 1996