Product code HBA— Neurology
ULTRACELL NEURO SPONGES
- Classification name
- Neurosurgical Paddie
- Device class
- Class 2
- Regulation
- 21 CFR 882.4700
- Advisory panel
- Neurology
- Total cleared
- 24
- First cleared
- Most recent
Market context for product code HBA
FDA has cleared devices under product code HBA between 1977 and 2020, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2020
- 2014
- 2013
- 2012
- 2008
- 2006
- 2003
- 2002
- 2000
- 1997
- 1995
- 1992
- 1991
- 1990
- 1988
Top applicants under product code HBA
Recent clearances under product code HBA
- K193346 — Codman Surgical Patties & Strips
- K140369 — MEDLINE NEURO SPONGE
- K112598 — AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
- K121822 — DELICOT
- K073576 — NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
- K062406 — AESCULAP NEURO PATTIES
- K031008 — AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)
- K020736 — TRAATEK COTTONOID PATTIES
- K014268 — NORAPAD PLAIN; NORAPAD TA
- K993019 — PACIFIC SURGICAL PATTIES
- K973083 — ULTRACELL NEURO SPONGES
- K962807 — AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES
- K970328 — ULTRACELL NEURO SPONGES
- K950647 — ULTRACELL NEURO SPONGES
- K914600 — NEUROLOGICAL SPONGE
- K923027 — NEURAY SURGICAL PATTIES AND STRIPS
- K904514 — STRUNG TELFA NON-ADHERENT SPONGE
- K902921 — RAYON NEUROLOGICAL SPONGE
- K891993 — COLLAGEN NEUROSPONGE
- K880402 — CODMAN SURGICAL PATTIE
- K862494 — POLYESTER SPONGE PATTIE
- K854713 — COTTON NEUROLOGICAL SPONGE
- K844594 — NEURO CUSTOM SURGICAL KIT
- K770894 — NEURO-SORB PATTIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.