Cleared Traditional

GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES (K972280) - FDA 510(k) Clearance

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

K972280 · Wilson Greatbatch Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
176d
Days
Class 2
Risk

K972280 is an FDA 510(k) clearance for the GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Wilson Greatbatch Technologies, Inc. (Clarence, US). The FDA issued a Cleared decision on December 11, 1997 after a review of 176 days - an extended review 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: 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 Wilson Greatbatch Technologies, Inc. devices

Submission Details

510(k) Number K972280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1997
Decision Date December 11, 1997
Days to Decision 176 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
61d slower than avg
Panel avg: 115d · This submission: 176d
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 K972280.
SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES
K980604 · Smith & Nephew, Inc. · May 1998
KSEA ENDOTIP SYSTEM
K973909 · KARL STORZ Endoscopy-America, Inc. · Feb 1998
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K974592 · Smith & Nephew, Inc. · Jan 1998
PANOVIEW PLUS TELESCOPE, 3.5MM, O,WL 300MM/25,WL 300MM/0,WL 180MM
K973359 · Richard Wolf Medical Instruments Corp. · Nov 1997
ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR
K972927 · Richard Wolf Medical Instruments Corp. · Nov 1997
DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES
K972471 · Smith & Nephew, Inc. · Oct 1997