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510(k) K904514

STRUNG TELFA NON-ADHERENT SPONGE by American Silk Sutures, Inc. — Product Code HBA

K904514 is an FDA 510(k) premarket notification submitted by American Silk Sutures, Inc. for the device "STRUNG TELFA NON-ADHERENT SPONGE". The FDA issued a decision of Substantially Equivalent on March 27, 1991. The device falls under product code HBA (Neurosurgical Paddie), a Class II device regulated under 21 CFR 882.4700. American Silk Sutures, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1991
Date Received
October 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Paddie
Device Class
Class II
Regulation Number
882.4700
Review Panel
NE
Submission Type

Other clearances by American Silk Sutures, Inc.

  • K922143 — AMERICAN BURN SHEET (August 10, 1992)
  • K902921 — RAYON NEUROLOGICAL SPONGE (September 18, 1990)
  • K872810 — STRUNG DENTAL ROLLS (December 4, 1987)
  • K872951 — AMERICAN BRAIN RETRACTOR COVER (September 16, 1987)
  • K872905 — AMERICAN NASAL SPONGE (September 4, 1987)
  • K872906 — SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE (August 11, 1987)
  • K872807 — NON-WOVEN TRACHEOTOMY SPONGE (August 4, 1987)
  • K872809 — GAUZE CHERRY SPONGE (August 4, 1987)
  • K872806 — STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG (August 4, 1987)
  • K872808 — CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8 (August 4, 1987)

Other clearances for product code HBA

  • K193346 — Codman Surgical Patties & Strips (November 20, 2020)
  • K140369 — MEDLINE NEURO SPONGE (September 26, 2014)
  • K112598 — AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) (June 20, 2013)
  • K121822 — DELICOT (September 10, 2012)
  • K073576 — NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES (February 22, 2008)
  • K062406 — AESCULAP NEURO PATTIES (September 15, 2006)
  • K031008 — AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) (May 9, 2003)
  • K020736 — TRAATEK COTTONOID PATTIES (June 3, 2002)
  • K014268 — NORAPAD PLAIN; NORAPAD TA (March 27, 2002)
  • K993019 — PACIFIC SURGICAL PATTIES (March 30, 2000)

FDA data resources