510(k) K890227
- Device
- SURGICAL PROBE
- Applicant
- KINETIC MEDICAL PRODUCTS
- 510(k) number
- K890227
- Product code
- HXB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-01-27
- Date received
- 1989-01-18
- Regulation
- 888.4540
- Classification name
- Probe
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES I LAUGHNER
- Address
- 4934 Peach St. Erie PA US 16509 16509
FDA Registration Numbers#
- 3003244954
- 9617297
- 1720747
- 1226544
- 8010273
- 3030514683
- 3004892425
- 8043496
- 2521877
- 3006846753
- 3003139373
- 8043746
- 3004111573
- 3010455030
- 3009554293
- 3009703496
- 3010071016
- 3015512299
- 3021336182
- 3011230048
- 3010375065
- 3002090132
- 3010370880
- 3012697315
- 3036756245
- 3034676720
- 8040233
- 3013546462
- 3003882387
- 3009499159
- 2080783
- 1828288
- 3005751028
- 3049552730
- 3033536312
- 3014615697
- 3010760216
- 8010733
- 9614107
- 1421101
- 9681540
- 3027339877
- 3005809810
- 1043214
- 3008110533
- 2320767
- 3004598675
- 1000426080
- 3017565094
- 1833053
- 3009590742
- 3027556548
- 3010331645
- 1423537
- 1526439
- 3005528784
- 1221763
- 3004774118
- 3001408183
- 9680518
- 3001297506
- 3010687973
- 1056350
- 1054241
- 3004944585
- 1421879
- 3003637761
- 2242737
- 1043534
- 3015516266
- 3013552417
- 3003032798
- 3015383864
- 3006524618
- 3025457095
- 9613926
- 3014004349
- 9611252
- 3010303097
- 3012234585
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 |
| 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 |
| K841971 | 2.5MM & 4MM PROBE K841969-LABELING | Stainless Mfg., Inc. | 1984-06-19 |
| 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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases