Cleared Traditional

K951090 - INTRODUCER

K951090 is the FDA 510(k) clearance for INTRODUCER by Ranfac, Corp.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K951090 · Ranfac, Corp. · General & Plastic Surgery device
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Jul 1995
Decision
124d
Days
Class 2
Risk

K951090 is an FDA 510(k) clearance for the INTRODUCER. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Ranfac, Corp. (Avon, US). The FDA issued a Cleared decision on July 11, 1995 after a review of 124 days - within the typical 510(k) review window.

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 Ranfac, Corp. devices

Submission Details

510(k) Number K951090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1995
Decision Date July 11, 1995
Days to Decision 124 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
9d slower than avg
Panel avg: 115d · This submission: 124d
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 517
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K951090.
KARL STORZ ENDOSCOPY POWDER BLOWER
K952443 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
ENDOPATH* TRISTAR FLAT BLADED SURGICAL OBTURATOR & SLEEVE
K952842 · Ethicon Endo-Surgery, Inc. · Jul 1995
QUESTUS DISPOSABLE ENDOSCOPIC KNIFE
K952926 · Wrightmedicaltechnologyinc · Jul 1995
ETHICON ARTHROSCOPIC KNOT PUSHER
K952814 · Ethicon, Inc. · Jul 1995
ENDOPATH AND PROXIMATE LINEAR CUTTERS AND STAPLERS
K951546 · Ethicon Endo-Surgery, Inc. · Jun 1995
INSULATED ELECTROSURGICAL INSTRUMENTS
K951986 · KARL STORZ Endoscopy-America, Inc. · Jun 1995