Cleared Traditional

3-CCD DIGITAL CAMERA (K970605) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970605 · Envision Medical Corp. · General & Plastic Surgery device
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May 1997
Decision
93d
Days
Class 2
Risk

K970605 is an FDA 510(k) clearance for the 3-CCD DIGITAL CAMERA. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Envision Medical Corp. (Santa Barbara, US). The FDA issued a Cleared decision on May 22, 1997 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Envision Medical Corp. devices

Submission Details

510(k) Number K970605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1997
Decision Date May 22, 1997
Days to Decision 93 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 354
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K970605.
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES
K971850 · Smith & Nephew, Inc. · Aug 1997
MVM 3.3 MM MICROENDOSCOPE
K972504 · KARL STORZ Endoscopy-America, Inc. · Aug 1997
INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR
K965001 · Intuitive Surgical, Inc. · Jul 1997
TROCAR CANNULA
K963115 · United States Surgical, A Division of Tyco Healthc · Feb 1997
TANDEMRX
K970054 · Boston Scientific Corp · Feb 1997
ETHICON ENDOSUTURE SYSTEM
K963329 · Ethicon, Inc. · Oct 1996