Cleared Traditional

K081995 - STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV)

K081995 is an FDA 510(k) clearance for STRYKER VISION ELECT WHDTV (STRYKER VE ..., manufactured by Stryker Endoscopy. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K081995 · Stryker Endoscopy · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
80d
Days
Class 2
Risk

K081995 is an FDA 510(k) clearance for the STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV). Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on October 2, 2008 after a review of 80 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 - K081995

510(k) Number K081995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2008
Decision Date October 02, 2008
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
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 K081995.
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K082156 · Teleflex Medical · Sep 2008
PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR
K080161 · Patton Surgical Corp. · May 2008
AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR
K081169 · Covidien Lp, Formerly Registered AS United States · May 2008
K081995 · STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV)
Download PDF FDA Summary Stryker Endoscopy