Cleared Traditional

K010620 - ENDOSCOPIC STAPLE REMOVAL INSTRUMENT

K010620 is an FDA 510(k) clearance for ENDOSCOPIC STAPLE REMOVAL INSTRUMENT, manufactured by Onux Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K010620 · Onux Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
77d
Days
Class 2
Risk

K010620 is an FDA 510(k) clearance for the ENDOSCOPIC STAPLE REMOVAL INSTRUMENT. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Onux Medical, Inc. (Hampton, US). The FDA issued a Cleared decision on May 17, 2001 after a review of 77 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.

View all Onux Medical, Inc. devices

FDA 510(k) Submission Details - K010620

510(k) Number K010620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2001
Decision Date May 17, 2001
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 1034
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K010620.
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K011359 · KARL STORZ Endoscopy-America, Inc. · Jun 2001
LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113
K010870 · Ethicon Endo-Surgery, Inc. · Jun 2001
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K010346 · KARL STORZ Endoscopy-America, Inc. · May 2001
CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1
K010789 · A & A Medical, Inc. · Apr 2001
DYONICS VISION 111 MOBILE VIDEO UNIT
K010489 · Smith & Nephew, Inc. · Apr 2001