WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY
FDA 510(k) clearance K980137 · decided 1998-01-30
Clearance details
- K-number
- K980137
- Device name
- WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY
- Applicant
- Worldwide Medical Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 1998-01-15
- Decision date
- 1998-01-30
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- LRO
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Woodbury, CT, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Medline General Surgery Tray (K213481) | Medline Industries, Inc. | 2022-05-24 |
| Medline Cardiovascular Procedure Kit (K212258) | Medline Industries, Inc. | 2021-12-03 |
| SURGICAL DRAPE KIT - D.I.R.R.A. SRL (K041080) | D.I.R.R.A. S.R.L. | 2004-11-30 |
| QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (K030721) | Ballard Medical Products | 2003-03-31 |
| AMSINO TRACHEOSTOMY CARE TRAY (K023276) | Amsino International, Inc. | 2002-12-09 |
| OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (K971061) | Opportunity, Inc. | 1997-06-11 |
| OPPORTUNITY INC. GENERAL PURPOSE TRAY (K971062) | Opportunity, Inc. | 1997-06-09 |
| NEUROLOGICAL OR CRANI TRAYS (PACKS) (K932221) | Associated Medical Products Co. | 1997-03-19 |
| PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (K970286) | Medline Industries, Inc. | 1997-03-10 |
| O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE (K965201) | Trinity Laboratories, Inc. | 1997-02-14 |
| RUNYON LARGE VOLUME PARACENTESIS KIT (K970187) | Gi Supply | 1997-02-14 |
| BASIC BIOPSY TRAY. DISPOSABLE, STERILE (K964921) | Trinity Laboratories, Inc. | 1997-01-22 |
Recalls involving this device
No recalls on record reference this clearance.