Cleared Special

K991703 - STRYKER HERMES-READY TOTAL PERFORMANCE ...

K991703 is the FDA 510(k) clearance for STRYKER HERMES-READY TOTAL PERFORMANCE ... by Stryker Instruments. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Special 510(k) pathway after a 8-day FDA review.

K991703 · Stryker Instruments · General & Plastic Surgery device
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May 1999
Decision
8d
Days
Class 2
Risk

K991703 is an FDA 510(k) clearance for the STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on May 27, 1999 after a review of 8 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.

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Submission Details

510(k) Number K991703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1999
Decision Date May 27, 1999
Days to Decision 8 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 115d · This submission: 8d
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 677
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K991703.
MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS
K991928 · Allegiance Healthcare Corp. · Jun 1999
DCI ENDOSCOPE
K991171 · Karl Storz Endoscopy · Jun 1999
DCI ENDOSCOPE
K991228 · Karl Storz Endoscopy · Jun 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