510(k) K970360
- Device
- MITEK SUTURE RETROGRADER
- Applicant
- MITEK PRODUCTS
- 510(k) number
- K970360
- Product code
- HWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-03-10
- Date received
- 1997-01-31
- Regulation
- 888.4540
- Classification name
- Passer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EDWARD F KENT
- Address
- 60 Glacier Dr. Westwood MA US 02090 02090
FDA Registration Numbers#
- 3002808227
- 3002579136
- 3014334038
- 3010635845
- 3019269298
- 3015974593
- 2953359
- 3012358417
- 3006981798
- 3043620689
- 3007507973
- 1220477
- 3004215117
- 1421879
- 2032098
- 9613926
- 3011302692
- 1825034
- 1219518
- 3007366790
- 2249529
- 3009971621
- 3012102437
- 8010099
- 3003418325
- 8010372
- 2950160
- 3006846753
- 3005528784
- 3013756169
- 1835998
- 3010060157
- 3006524618
- 3033536312
- 1421101
- 8040278
- 2011171
- 3008747271
- 1043534
- 9610612
- 3010303097
- 1054811
- 1221051
- 3008770252
- 1056350
- 3031564283
- 3014023545
- 3011295718
- 3034532468
- 3008837339
- 3005180920
- 3026133770
- 3038503932
- 2936485
- 8010177
- 3010667733
- 1017294
- 3011061237
- 3013497507
- 3009255580
- 3007663067
- 2183456
- 3020584246
- 3005067367
- 3030535035
- 3003139373
- 1526534
- 3013846070
- 3002907620
- 3005575604
- 3010041511
- 3006460162
- 3014302784
- 2031009
- 9615004
- 1226230
- 3045853999
- 3007738736
- 3011137372
- 1064017
Source Documents#
Other 510(k) Records For Product Code HWQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K920621 | ACUFEX PASSING PINS AND SURGICAL WIRE | Acufex Microsurgical, Inc. | 1993-05-05 |
| K923381 | SOFT TISSUE EXPANDER | Acufex Microsurgical, Inc. | 1993-05-05 |
| K885311 | MENISCUS MENDER II LOOP | Instrument Makar, Inc. | 1989-02-09 |
| K843592 | VICO MICRO SURGICAL INSTRUMENTS | Visitec Co. | 1984-10-05 |
| K841622 | SOFT-TISSUE INSTRUMENT | Plastafil, Inc. | 1984-07-11 |
| K841623 | SLOTTED SOFT-TISSUE INSTRUMENT | Plastafil, Inc. | 1984-07-11 |
| K811679 | SILASTIC TENDON PASSER H.P. | Dow Corning Corp. Healthcare Industries Materials | 1981-07-10 |
| K791960 | ROTH-KENNEDY PASSER | 3M Company | 1979-10-04 |
Legacy Summary#
summary
FDA Review#
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