Cleared Traditional

K861761 - ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE

K861761 · Travenol Laboratories, S.A. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1986
Decision
114d
Days
-
Risk

K861761 is an FDA 510(k) clearance for the ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE. 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 August 28, 1986 after a review of 114 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K861761

510(k) Number K861761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1986
Decision Date August 28, 1986
Days to Decision 114 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 129d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

LPZ Device Classification - Class 0,

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

Regulatory Peers - LPZ Container, Frozen Donor Tissue Storage

Devices cleared under the same product code (LPZ) and FDA review panel - the closest regulatory comparables to K861761.
CRYOBAG, MODEL CB
K021702 · Origen Biomedical, Inc. · Aug 2002
CRYOBAG
K915471 · Janus Biomedical, Inc. · Mar 1994
TAMPER HAMPER
K863872 · Hydro-Med Products, Inc. · Feb 1987
AMPU-PAK
K860511 · Ammerman Medical Enterprises, Inc. · Aug 1986
ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR
K853663 · Travenol Laboratories, S.A. · Apr 1986
K861761 · ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE
Download PDF Travenol Laboratories…