Cleared Traditional

K952906 - THE TULIP LAPAROSCOPE SHEATH 6MM SINGLE...

K952906 is an FDA 510(k) clearance for THE TULIP LAPAROSCOPE SHEATH 6MM SINGLE..., manufactured by The Tulip Mfg. Co.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K952906 · The Tulip Mfg. Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
213d
Days
Class 2
Risk

K952906 is an FDA 510(k) clearance for the THE TULIP LAPAROSCOPE SHEATH 6MM SINGLE STOPCOCK. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by The Tulip Mfg. Co. (Mesa, US). The FDA issued a Cleared decision on January 22, 1996 after a review of 213 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 The Tulip Mfg. Co. devices

FDA 510(k) Submission Details - K952906

510(k) Number K952906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1995
Decision Date January 22, 1996
Days to Decision 213 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
98d slower than avg
Panel avg: 115d · This submission: 213d
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 K952906.
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OTV-S5 OES VIDEO SYSTEM
K955404 · Olympus America, Inc. · Feb 1996
3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY
K943307 · Olympus America, Inc. · Dec 1995
AUTO SUTURE SUTURE CLOSURE
K954853 · United States Surgical, A Division of Tyco Healthc · Dec 1995
DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES]
K954174 · Origin Medsystems, Inc. · Nov 1995