Cleared Traditional

K970949 - SMITH & NEPHEW MIS INSTRUMENTS

K970949 is an FDA 510(k) clearance for SMITH & NEPHEW MIS INSTRUMENTS, manufactured by Smith & Nephew 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 40-day FDA review.

K970949 · Smith & Nephew Endoscopy, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
40d
Days
Class 2
Risk

K970949 is an FDA 510(k) clearance for the SMITH & NEPHEW MIS INSTRUMENTS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Smith & Nephew Endoscopy, Inc. (Mansfield, US). The FDA issued a Cleared decision on April 23, 1997 after a review of 40 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 Smith & Nephew Endoscopy, Inc. devices

FDA 510(k) Submission Details - K970949

510(k) Number K970949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1997
Decision Date April 23, 1997
Days to Decision 40 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 115d · This submission: 40d
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 1066
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K970949.
SOLOS 10MM OPERATING LAPAROSCOPE
K970917 · Woodbine Optical Corp. · Jun 1997
3-CCD DIGITAL CAMERA
K970605 · Envision Medical Corp. · May 1997
INSTRUMENT HOLDER
K970900 · Contour Fabricators, Inc. · May 1997
INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP
K970754 · Innerdyne, Inc. · Apr 1997
3 DIMENSIONAL VIDEO ENDOSCOPE
K970214 · Oktas · Apr 1997
VISTA MINI CAMERA SYSTEM
K970369 · Oktas · Apr 1997