Cleared Traditional

K970888 - IOTEC TROCAR AND FLEXIBLE CANNULA

K970888 is an FDA 510(k) clearance for IOTEC TROCAR AND FLEXIBLE CANNULA, manufactured by Iotec Industries. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K970888 · Iotec Industries · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
304d
Days
Class 2
Risk

K970888 is an FDA 510(k) clearance for the IOTEC TROCAR AND FLEXIBLE CANNULA. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Iotec Industries (Fort Worth, US). The FDA issued a Cleared decision on January 9, 1998 after a review of 304 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 Iotec Industries devices

FDA 510(k) Submission Details - K970888

510(k) Number K970888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1997
Decision Date January 09, 1998
Days to Decision 304 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
189d slower than avg
Panel avg: 115d · This submission: 304d
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 913
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K970888.
SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK
K973046 · General Surgical Innovations · Jan 1998
KRONNER LOW PROFILE SCOPE HOLDER
K973543 · Kronner Prototypes, Inc. · Jan 1998
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K974592 · Smith & Nephew, Inc. · Jan 1998
KSEA PLASTIC TROCARS
K974366 · Karl Storz Endoscopy · Jan 1998
S-57 VIDEO IMAGING SYSTEM
K973794 · Sopro · Jan 1998
S-52 ELECTRONIC VIDEO LAPAROSCOPE
K973795 · Sopro · Jan 1998