Cleared Traditional

K936225 - TS1 TURTLE(TM) SYRINGE

K936225 is an FDA 510(k) clearance for TS1 TURTLE(TM) SYRINGE, manufactured by Kershenstine Diamond, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 512-day FDA review.

K936225 · Kershenstine Diamond, Inc. · General Hospital
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May 1995
Decision
512d
Days
Class 2
Risk

K936225 is an FDA 510(k) clearance for the TS1 TURTLE(TM) SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Kershenstine Diamond, Inc. (Metairie, US). The FDA issued a Cleared decision on May 16, 1995 after a review of 512 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Kershenstine Diamond, Inc. devices

FDA 510(k) Submission Details - K936225

510(k) Number K936225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date May 16, 1995
Days to Decision 512 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
383d slower than avg
Panel avg: 129d · This submission: 512d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 Hospital devices follow this clearance model.

Regulatory Peers - MEG Syringe, Antistick

All 123
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K936225.
ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE
K973301 · Retractable Technologies, Inc. · Nov 1997
ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE
K970803 · Retractable Technologies, Inc. · May 1997
UNIVEC NON-REUSABLE SYRINGE
K933469 · Univec, Inc. · Apr 1996
HYPO(R) SAFETY CARTRIDGE SYRINGE
K936040 · Smith & Nephew, Inc. · May 1995