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510(k) K770894

NEURO-SORB PATTIES by Instranetics, Inc. — Product Code HBA

K770894 is an FDA 510(k) premarket notification submitted by Instranetics, Inc. for the device "NEURO-SORB PATTIES". The FDA issued a decision of Substantially Equivalent on June 20, 1977. The device falls under product code HBA (Neurosurgical Paddie), a Class II device regulated under 21 CFR 882.4700. Instranetics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1977
Date Received
May 16, 1977
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 Instranetics, Inc.

  • K823430 — INSTRA-SAFE (January 7, 1983)
  • K811822 — TIP-VU (July 20, 1981)
  • K811823 — SHARPS CADDY FB (July 20, 1981)
  • K811824 — CAUTERY CADDY PAD (July 20, 1981)
  • K810294 — LINE CADDY (February 26, 1981)
  • K810208 — BLADE SAFE (February 12, 1981)
  • K802865 — SAFE T COUNT (December 18, 1980)
  • K802866 — SHARPS CADDY MAGNETIC & SHARPS CADDY FOA (November 17, 1980)
  • K781575 — DISPOSABLE LYMPHANGIOGRAM SET (December 4, 1978)

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