FDA Product Code
FDA Product Code HAE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4840
510(k) Clearances — 37 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260446 | Tontarra Punches and Rongeurs | Tontarra Medizintechnik GmbH | 2026-09-15 | Traditional | PDF ↗ |
| K242759 | Geister K-Rex rongeurs | Geister Medizin Technik GmbH | 2025-06-06 | Traditional | PDF ↗ |
| K223596 | SQ.line KERRISON | Aesculap, Inc. | 2023-06-29 | Traditional | PDF ↗ |
| K230256 | Rebellion, Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | 2023-03-03 | Special | PDF ↗ |
| K221818 | Rebellion; Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | 2022-10-07 | Special | PDF ↗ |
| K210741 | KLS Martin Neuro Rongeurs | KLS-Martin L.P. | 2022-06-03 | Traditional | PDF ↗ |
| K200768 | Rebellion, Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | 2021-05-04 | Traditional | PDF ↗ |
| K200383 | Wiggins Medical Surgical Instruments | Wiggins Medical | 2020-07-21 | Traditional | PDF ↗ |
| K200387 | Ace Medical Surgical Instruments | Ace Medical | 2020-07-21 | Traditional | PDF ↗ |
| K180949 | Steribite | Rjr Surgical, Inc. | 2018-11-08 | Traditional | PDF ↗ |
| K161744 | Symmetry Sharp Kerrison Rongeur | Symmetry Surgical, Inc. | 2016-09-07 | Special | PDF ↗ |
| K153243 | Fehling-Punches | Fehling Instruments GmbH & Co. KG | 2016-08-04 | Traditional | PDF ↗ |
| K152734 | Kerrison Rongeurs | Vitalitec Medizintechnik GmbH | 2016-06-18 | Traditional | PDF ↗ |
| K150468 | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | K2 Medical GmbH & Co. KG | 2016-02-29 | Traditional | PDF ↗ |
| K150428 | Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs | Integra Lifesciences Corp. | 2015-04-16 | Special | PDF ↗ |
| K131851 | OSTEOMED NEURO RONGEUR | Osteomed | 2013-12-06 | Traditional | PDF ↗ |
| K130541 | SYMMETRY KERRISON DISPOSABLE TIP RONGEURS | Symmetry Surgical | 2013-08-05 | Traditional | PDF ↗ |
| K113073 | IO-TOME DEVICE | Baxano, Inc. | 2012-07-27 | Traditional | PDF ↗ |
| K113533 | NEURO CHECK DEVICE WITH IO-FLEX WIRE | Baxano, Inc. | 2012-04-11 | Special | PDF ↗ |
| K100958 | MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES | Baxano, Inc. | 2010-07-23 | Special | PDF ↗ |
| K092227 | JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS | Integra Lifesciences Corp. | 2010-02-17 | Traditional | PDF ↗ |
| K081651 | INSTRUMED RONGEUR | Instrumed International, Inc. | 2008-08-08 | Traditional | PDF ↗ |
| K080494 | BAXANO ULTRA LOW PROFILE RONGEUR | Baxano, Inc. | 2008-03-04 | Special | PDF ↗ |
| K063231 | MICROBLADE SHAVER AND ACCESSORIES | Baxano, Inc. | 2007-04-16 | Traditional | PDF ↗ |
| K062711 | ULTRA LOW PROFILE RONGEUR | Baxano, Inc. | 2007-03-07 | Traditional | PDF ↗ |
| K023868 | DAN KERRISON RONGEURS, MODELS K1 + BILLY 1 | Dannoritzer Medical Instruments | 2003-02-07 | Traditional | PDF ↗ |
| K954699 | BRAY RONGEUR | Johnson & Johnson Professionals, Inc. | 1995-12-06 | Traditional | PDF ↗ |
| K943583 | KERRISON RONGEURS | Enterprise Medical Corp. | 1995-02-21 | Traditional | PDF ↗ |
| K943635 | ULTRA-LINE RONGEUR | V. Mueller Neuro/Spine | 1994-12-07 | Traditional | PDF ↗ |
| K943116 | AUTO SUTURE KERRISON SPINAL RONGEUR | United States Surgical, A Division of Tyco Healthc | 1994-07-27 | Traditional | PDF ↗ |
| K933978 | NEDBOND EJECTOR KERRISON RONGEUR | Redmond Neurotechnologies Corp. | 1994-01-12 | Traditional | PDF ↗ |
| K903151 | INTERVERTEBRAL DISC RONGEUR | Von Zeppelin GmbH | 1990-12-11 | Traditional | PDF ↗ |
| K903401 | SPECIAL RONGEUR | Sur-Med Instruments, Inc. | 1990-08-10 | Traditional | PDF ↗ |
| K901313 | INSTRUMENTS FOR NEUROLOGICAL SURGERY | Von Zeppelin GmbH | 1990-07-23 | Traditional | PDF ↗ |
| K901372 | LAMINECTOMY RONGEUR | Zeppelin GmbH | 1990-06-28 | Traditional | PDF ↗ |
| K892535 | NEUROLOGICAL RONGEURS - VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-05-11 | Traditional | PDF ↗ |
| K875043 | RONGEUR (NEUROSURGICAL INSTRUMENTS) | Solway, Inc. | 1988-01-22 | Traditional | PDF ↗ |
Product code HAE · Class II · Neurology. Data: openFDA.