Cleared Traditional

K853663 - ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR (FDA 510(k) Clearance)

K853663 · Travenol Laboratories, S.A. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
218d
Days
-
Risk

K853663 is an FDA 510(k) clearance for the ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR. Classified as Container, Frozen Donor Tissue Storage (product code LPZ).

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on April 9, 1986 after a review of 218 days - an extended review cycle.

This device falls under the General Hospital FDA review panel. 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K853663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1985
Decision Date April 09, 1986
Days to Decision 218 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 128d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LPZ Container, Frozen Donor Tissue Storage
Device Class -