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#
- 3006981798
- 2183449
- 9610612
- 1219518
- 3013756169
- 3014334038
- 3015974593
- 2183456
- 3008792120
- 3006513362
- 3020584246
- 3005809810
- 8010177
- 3007663067
- 3009255580
- 3019269298
- 3010303097
- 8044098
- 3008110533
- 3010047454
- 9613910
- 3005067367
- 2936485
- 3002907620
- 3009971621
- 2011171
- 1421101
- 3010331645
- 1833824
- 3009540749
- 3004608878
- 3042255021
- 3043620689
- 9611278
- 3008747271
- 8010372
- 3006460162
- 1220477
- 3013497507
- 3008812560
- 8044102
- 9611112
- 3010273872
- 3005180920
- 3002808227
- 1020279
- 3004983210
- 3033536312
- 1061927
- 1825034
- 2031917
- 2953359
- 3011061237
- 8030607
- 3009513193
- 1822565
- 3031564283
- 8043971
- 3010536692
- 1526534
- 1221051
- 1017294
- 8040278
- 1220246
- 3002807315
- 3026133770
- 3003418325
- 1836161
- 3021477808
- 3003694247
- 3010659131
- 3004215117
- 2916714
- 3002579136
- 2031009
- 3007319107
- 1054811
- 3034532468
- 3000931034
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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