Probe
An orthopedic probe is a slender, handheld instrument used during arthroscopic or open orthopedic procedures to palpate, test, and assess the integrity of joint surfaces, ligaments, and cartilage. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk and general controls only. Product code HXB falls under the Orthopedic medical specialty.
Research product code HXB in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HXB
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K960539 | DIAO HAND SURGERY SET | Jul 23, 1996 | Substantially Equivalent | Kinetikos Medical, Inc. |
| K943472 | COHORT AVB RETRACTOR SYSTEM | Oct 20, 1994 | Substantially Equivalent | Cohort Medical Products Group, Inc. |
| K912843 | FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE | Sep 24, 1991 | Substantially Equivalent | Flexmedics |
| K890227 | SURGICAL PROBE | Jan 27, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K873652 | HOOK PROBE #TM-1376 | Nov 02, 1987 | Substantially Equivalent | Arthropedics, Inc. |
| K873651 | BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375 | Nov 02, 1987 | Substantially Equivalent | Arthropedics, Inc. |
| K863149 | BOWEN PROBE | Sep 05, 1986 | Substantially Equivalent | Bowen & Company, Inc. |
| K841971 | 2.5MM & 4MM PROBE K841969-LABELING | Jun 19, 1984 | Substantially Equivalent | Stainless Mfg., Inc. |
| K840558 | SHUTT PRECISION PROBES | Apr 25, 1984 | Substantially Equivalent | Concept, Inc. |
| K810294 | LINE CADDY | Feb 26, 1981 | Substantially Equivalent | Instranetics, Inc. |
| K802951 | I.M PROBES | Dec 17, 1980 | Substantially Equivalent | Hogan & Hartson |
| K802479 | SURGICAL KNIVES & PROBES | Oct 31, 1980 | Substantially Equivalent | Eder Instrument Co, Inc. |
| K800729 | PROBE | Apr 08, 1980 | Substantially Equivalent | Stainless Mfg., Inc. |
| K800444 | GOLDEN RETRIEVERS OR SILVER RETRIEVERS | Mar 05, 1980 | Substantially Equivalent | Instrument Makar, Inc. |
| K800274 | ACUFEX PROBES | Feb 19, 1980 | Substantially Equivalent | Acufex Microsurgical, Inc. |
FEI Numbers
This FDA classification entry is associated with 373 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 373 registration numbers. Click on an entry to view related FDA registrations.