Cleared Traditional

K921208 - ACCU-BEAM TUBE SET

K921208 is the FDA 510(k) clearance for ACCU-BEAM TUBE SET by Tti Medical. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 446-day FDA review.

K921208 · Tti Medical · General & Plastic Surgery device
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Jun 1993
Decision
446d
Days
Class 2
Risk

K921208 is an FDA 510(k) clearance for the ACCU-BEAM TUBE SET. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Tti Medical (Pleasanton, US). The FDA issued a Cleared decision on June 1, 1993 after a review of 446 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 & Plastic Surgery submissions.

View all Tti Medical devices

Submission Details

510(k) Number K921208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1992
Decision Date June 01, 1993
Days to Decision 446 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
331d slower than avg
Panel avg: 115d · This submission: 446d
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 694
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K921208.
ENDOPATH* DISPOSABLE INTRODUCER
K931237 · Ethicon, Inc. · Jun 1993
ENDOPATH DISPOSABLE KNOT PUSHER
K931238 · Ethicon, Inc. · Jun 1993
ENDOPATH II DISPOSABLE SURGICAL TROCAR & SLEEVE
K932282 · Ethicon Endo-Surgery, Inc. · Jun 1993
MANUAL SURGICAL INSTRUMENTS
K921925 · 3M Health Care, Ltd. · May 1993
PRE-TIED LOOP SUTURE CANNULA
K925914 · Ethicon, Inc. · May 1993
GUIDE WIRE FOR LAPOROSCOPIC USE
K926214 · Terumo Medical Corp. · Apr 1993