Cleared Traditional

SAFE TEE (K955076) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K955076 · Pearson Strach Medical · General Hospital
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Apr 1996
Decision
153d
Days
Class 2
Risk

K955076 is an FDA 510(k) clearance for the SAFE TEE. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Pearson Strach Medical (Keller, US). The FDA issued a Cleared decision on April 2, 1996 after a review of 153 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.1500 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Pearson Strach Medical devices

Submission Details

510(k) Number K955076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1995
Decision Date April 02, 1996
Days to Decision 153 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
24d slower than avg
Panel avg: 129d · This submission: 153d
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 Hospital devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 399
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K955076.
ETHICON ENDOSUTURE SYSTEM
K963329 · Ethicon, Inc. · Oct 1996
KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY
K960903 · KARL STORZ Endoscopy-America, Inc. · Aug 1996
MODIFIED HAND INSTRUMENT DEVICES
K960748 · United States Surgical, A Division of Tyco Healthc · Apr 1996
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