PMN VOLZ CURETTES
FDA 510(k) clearance K831367 · decided 1983-05-25
Clearance details
- K-number
- K831367
- Device name
- PMN VOLZ CURETTES
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1983-04-26
- Decision date
- 1983-05-25
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- FZS
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- White City, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SURGICAL CURETTE (K932493) | Whitney Products, Inc. | 1994-01-07 |
| KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD (K902000) | Kevtek Medical Products, Inc. | 1990-08-21 |
| CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE (K892521) | Cymed, Inc. | 1989-05-01 |
| CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER (K891888) | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| ACU-CURETTE (K891334) | Acuderm, Inc. | 1989-04-11 |
| ADENOID CURETTE (K890366) | Kinetic Medical Products | 1989-02-03 |
| MICRODISCECTOMY CURETTE SET (K875292) | T. Korossurgical Instruments Corp. | 1988-01-29 |
| STRAIGHT CUP CURRETTE, 1.7MM (K871925) | Arthropedics, Inc. | 1987-06-01 |
| RANDALL CURETTE (K854888) | Euro-Med Intl. | 1985-12-24 |
| NOVAK CURETTE (K854899) | Euro-Med Intl. | 1985-12-24 |
| HOPPENSTEIN MICROSURGICAL SPINAL INSTRU (K842701) | Downs Surgical , Ltd. | 1984-08-02 |
| LUO CURRETTES #3211 (K831119) | Pmt, Inc. | 1983-05-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011) | 3M Company | 1994-11-28 |
| CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010) | 3M Company | 1994-05-19 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006) | 3M Company | 1992-12-31 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009) | 3M Company | 1992-03-13 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008) | 3M Company | 1992-01-28 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007) | 3M Company | 1990-10-17 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005) | 3M Company | 1990-03-08 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004) | 3M Company | 1989-11-22 |