STRUNG TELFA NON-ADHERENT SPONGE— 510(k) K904514
Substantially EquivalentAmerican Silk Sutures, Inc.
FDA 510(k) clearance K904514 for STRUNG TELFA NON-ADHERENT SPONGE, Substantially Equivalent on 1991-03-27. Applicant: American Silk Sutures, Inc.. Device class: 2.
Clearance details
- Applicant
- American Silk Sutures, Inc.
- Product code
- Code HBA
- Device class
- Class 2
- Regulation
- 21 CFR 882.4700
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tamarac, FL, US
Recent devices under product code HBA
view allMore clearances from American Silk Sutures, Inc.
view allRecalls naming K904514
K-number listed on FDA's recall record- Z-1800-2016 — American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Z-1801-2016 — American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Z-1802-2016 — American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Z-1803-2016 — American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Z-1804-2016 — American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Z-1805-2016 — American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Z-1806-2016 — American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K904514.
Data sourced from openFDA. This site is unofficial and independent of the FDA.