Cleared Traditional

K980623 - N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TE...

K980623 is an FDA 510(k) clearance for N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TE..., manufactured by N-Tech Endoscopy, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K980623 · N-Tech Endoscopy, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
72d
Days
Class 2
Risk

K980623 is an FDA 510(k) clearance for the N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by N-Tech Endoscopy, Inc. (Mundelein, US). The FDA issued a Cleared decision on April 30, 1998 after a review of 72 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 N-Tech Endoscopy, Inc. devices

FDA 510(k) Submission Details - K980623

510(k) Number K980623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1998
Decision Date April 30, 1998
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
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 724
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K980623.
STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL
K974771 · Stryker Endoscopy · May 1998
VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM
K981700 · Origin Medsystems, Inc. · May 1998
SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES
K980604 · Smith & Nephew, Inc. · May 1998
COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES
K980079 · Lumenis, Inc. · Apr 1998
ENDOPATH AND PROXIMATE LINEAR CUTTERS
K980023 · Ethicon Endo-Surgery, Inc. · Mar 1998
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
K980022 · Ethicon Endo-Surgery, Inc. · Mar 1998