Cleared Traditional

K950243 - TITAN INSUFFLATION NEEDLE

K950243 is an FDA 510(k) clearance for TITAN INSUFFLATION NEEDLE, manufactured by Endolap, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K950243 · Endolap, Inc. · General & Plastic Surgery device
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Apr 1995
Decision
76d
Days
Class 2
Risk

K950243 is an FDA 510(k) clearance for the TITAN INSUFFLATION NEEDLE. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Endolap, Inc. (Orlando, US). The FDA issued a Cleared decision on April 6, 1995 after a review of 76 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 Endolap, Inc. devices

FDA 510(k) Submission Details - K950243

510(k) Number K950243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1995
Decision Date April 06, 1995
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
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 K950243.
KARL STORZ PEDIATRIC PYLORIC SPREADER, PYLOROTOME, ENDOTOME
K951252 · KARL STORZ Endoscopy-America, Inc. · Apr 1995
ENDOPATH OPTICAL ACCESS NEEDKLE
K951444 · Ethicon Endo-Surgery, Inc. · Apr 1995
SYMBIOSIS BIPOLAR SCISSORS
K951387 · Symbiosis Corp. · Apr 1995
KSEA STEINER ELECTROMECHANIC MORCELLATOR
K950339 · KARL STORZ Endoscopy-America, Inc. · Apr 1995
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE
K951251 · KARL STORZ Endoscopy-America, Inc. · Apr 1995
INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER
K950277 · Boston Scientific Corp · Mar 1995