Cleared Traditional

K781336 - SURGITEK DISPOSABLE FLO-RESTER

K781336 is an FDA 510(k) clearance for SURGITEK DISPOSABLE FLO-RESTER, manufactured by Medical Engineering Corp.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K781336 · Medical Engineering Corp. · Cardiovascular device
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Oct 1978
Decision
68d
Days
Class 1
Risk

K781336 is an FDA 510(k) clearance for the SURGITEK DISPOSABLE FLO-RESTER. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Medical Engineering Corp. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1978 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - the FDA cardiovascular device oversight 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 Medical Engineering Corp. devices

FDA 510(k) Submission Details - K781336

510(k) Number K781336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1978
Decision Date October 10, 1978
Days to Decision 68 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 125d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

DWS Device Classification - Class 1, General Controls

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DWS Instruments, Surgical, Cardiovascular

All 52
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K781336.
CARDIOVASCULAR INSTRUMENTS-VARIOUS
K791710 · Edward Weck, Inc. · Sep 1979
SILICONE SURGICAL VESSEL LOOPS
K791370 · Conphar, Inc. · Aug 1979
GRAFT TUNNELER
K790124 · Narco Scientific · Feb 1979
AORTIC PUMP
K780567 · Ethicon, Inc. · Apr 1978
HUANG VEIN HOLDER, #21-8011
K771026 · Codman & Shurtleff, Inc. · Jun 1977
ANASTOMASIS OCCLUDER
K761328 · Medical Engineering Corp. · Feb 1977