# K970453: B. Braun Medical Inc. Transorbent and Thinsite Border Dressing

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Apr 11, 1997 after 79 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Transorbent Wound Dressing: named in the summary without a submission number
- (no number) ThinSite (Transorb Thin) Wound Dressing: named in the summary without a submission number
- (no number) B. F. Goodrich Biofilm Transorbent Ulcer and Wound Dressing: named in the summary without a submission number
- (no number) Tegasorb™ THIN Hydrocolloid Dressing: named in the summary without a submission number
- (no number) Tegasorb™ Ulcer Dressing: named in the summary without a submission number
- (no number) Tegaderm™ HP Transparent Dressing: named in the summary without a submission number
- (no number) Duoderm Flexible Hydroactive Dressing: named in the summary without a submission number
- (no number) Duoderm Hydroactive Dressing and CGF Dressing: named in the summary without a submission number
- (no number) Duoderm CGF Border Dressings: named in the summary without a submission number
- (no number) Duoderm CGF Extra Thin: named in the summary without a submission number
- (no number) Nu-Derm Foam Island Dressings: named in the summary without a submission number
- (no number) Band-Aid Brand Surgical Dressings: named in the summary without a submission number

## Indications for use
The Transorbent and ThinSite Topical Border Wound Dressings are intended for use in the management of partial and full thickness wounds, Stage I - IV pressure ulcers, arterial and venous stasis leg ulcers, and to aid in the prevention of skin breakdown. They are also intended for use in post-surgical wounds, biopsy sites, minor abrasions and lacerations, suture sites, partial thickness and full thickness dermatological sites, laparoscopic incisional sites, and drainage tube sites.

Source page: https://510kreport.com/device/K970453
Methodology: https://510kreport.com/methodology