Cleared Traditional

DEEPVISON (K942910) - FDA 510(k) Clearance

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

K942910 · Automated Medical Products Corp. · General & Plastic Surgery device
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Jul 1995
Decision
395d
Days
Class 2
Risk

K942910 is an FDA 510(k) clearance for the DEEPVISON. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Automated Medical Products Corp. (Washington, US). The FDA issued a Cleared decision on July 21, 1995 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Automated Medical Products Corp. devices

Submission Details

510(k) Number K942910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1994
Decision Date July 21, 1995
Days to Decision 395 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
280d slower than avg
Panel avg: 115d · This submission: 395d
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 399
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K942910.
BIPOLAR COAGULATING FORCEPS
K953509 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
KARL STORZ ENDOSCOPY POWDER BLOWER
K952443 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
QUESTUS DISPOSABLE ENDOSCOPIC KNIFE
K952926 · Wrightmedicaltechnologyinc · Jul 1995
ETHICON ARTHROSCOPIC KNOT PUSHER
K952814 · Ethicon, Inc. · Jul 1995
INSULATED ELECTROSURGICAL INSTRUMENTS
K951986 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
K951625 · KARL STORZ Endoscopy-America, Inc. · May 1995