510(k) K841971
- Device
- 2.5MM & 4MM PROBE K841969-LABELING
- Applicant
- STAINLESS MFG., INC.
- 510(k) number
- K841971
- Product code
- HXB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-06-19
- Date received
- 1984-05-14
- Regulation
- 888.4540
- Classification name
- Probe
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3015974593
- 3011625373
- 3010687973
- 1722511
- 9612075
- 3009882675
- 3036795921
- 3008455034
- 1043534
- 3014004349
- 3014938863
- 3011585752
- 3006765019
- 1051526
- 1421879
- 3010455030
- 1423537
- 3009590742
- 3012818475
- 3030514683
- 3003418325
- 8030607
- 3003334541
- 3011600579
- 3005726885
- 9680002
- 3016852448
- 3005596514
- 1061124
- 3010370500
- 3008902714
- 8010298
- 9616088
- 3006460162
- 3004111573
- 3013875765
- 2183449
- 3003637761
- 9611024
- 3006059835
- 3010071016
- 3002834291
- 3009165919
- 1220246
- 9611102
- 3019404837
- 9611252
- 3007887127
- 1828288
- 3006891796
- 9617297
- 3002675176
- 3030446844
- 3006524618
- 3009888740
- 3010531060
- 3029082594
- 3020899789
- 3030188041
- 3039169546
- 3005225959
- 3008110533
- 3010536692
- 3009106092
- 3016965929
- 3008812560
- 3008850074
- 8040263
- 3013358456
- 1935627
- 8010252
- 3004892425
- 3008285983
- 3016438694
- 3003244954
- 3010375065
- 3033509898
- 3010370880
- 3029780995
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HXB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960539 | DIAO HAND SURGERY SET | Kinetikos Medical, Inc. | 1996-07-23 |
| K943472 | COHORT AVB RETRACTOR SYSTEM | Cohort Medical Products Group, Inc. | 1994-10-20 |
| K912843 | FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE | Flexmedics | 1991-09-24 |
| K890227 | SURGICAL PROBE | Kinetic Medical Products | 1989-01-27 |
| K873651 | BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375 | Arthropedics, Inc. | 1987-11-02 |
| K873652 | HOOK PROBE #TM-1376 | Arthropedics, Inc. | 1987-11-02 |
| K863149 | BOWEN PROBE | Bowen & Company, Inc. | 1986-09-05 |
| K840558 | SHUTT PRECISION PROBES | Concept, Inc. | 1984-04-25 |
| K810294 | LINE CADDY | Instranetics, Inc. | 1981-02-26 |
| K802951 | I.M PROBES | Hogan & Hartson | 1980-12-17 |
| K802479 | SURGICAL KNIVES & PROBES | Eder Instrument Co, Inc. | 1980-10-31 |
| K800729 | PROBE | Stainless Mfg., Inc. | 1980-04-08 |
| K800444 | GOLDEN RETRIEVERS OR SILVER RETRIEVERS | Instrument Makar, Inc. | 1980-03-05 |
| K800274 | ACUFEX PROBES | Acufex Microsurgical, Inc. | 1980-02-19 |
Legacy Summary#
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FDA Review#
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