Cleared Special

MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS (K991928) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K991928 · Allegiance Healthcare Corp. · General & Plastic Surgery device
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Jun 1999
Decision
17d
Days
Class 2
Risk

K991928 is an FDA 510(k) clearance for the MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on June 25, 1999 after a review of 17 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Allegiance Healthcare Corp. devices

Submission Details

510(k) Number K991928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1999
Decision Date June 25, 1999
Days to Decision 17 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

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 426
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K991928.
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW232
K992612 · Ethicon Endo-Surgery, Inc. · Oct 1999
OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM, ANGLED, OPERATING LAPAROSCOPE, 10-5,,. OBLIQUE, D
K991718 · Richard Wolf Medical Instruments Corp. · Aug 1999
TROCAR SYSTEM ACCORDING TO HASSON
K990237 · Olympus America, Inc. · Jul 1999
SMITH & NEPHEW HANDPORT SYSTEM
K990414 · Smith & Nephew, Inc. · Apr 1999
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
K990028 · Ethicon Endo-Surgery, Inc. · Apr 1999
INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1
K990188 · Intuitive Surgical, Inc. · Apr 1999