ULTRASOUND TRANSMISSION GEL
FDA 510(k) clearance K905545 · decided 1991-03-29
Clearance details
- K-number
- K905545
- Device name
- ULTRASOUND TRANSMISSION GEL
- Applicant
- Arbo Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-12-11
- Decision date
- 1991-03-29
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- JOT
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Stratford, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RFG-DGP DISPOSABLE GROUNDING PADS (K923647) | Radionics, Inc. | 1992-11-09 |
| ULTRASOUND COUPLING GEL (K904418) | Geno Laboratories | 1991-02-11 |
| TRIA-SONIC ULTRA SOUND TRANSMISSION GEL (K901217) | H & P Industries, Inc. | 1990-06-22 |
| STERILE ULTRASOUND TRANSMISSION GEL (K894490) | Swedish Trade Council USA | 1989-10-05 |
| ULTRASONIC TRANSMISSION GEL (K884503) | Herbert Stanley Co. | 1989-02-13 |
| STERILIZED OMNI GEL (K872519) | Echo Ultrasound | 1987-08-03 |
| ULTRASOUND TRANSDUCER GEL, STERILE (K871565) | Amedic USA | 1987-07-15 |
| R2 ELECTROSURG. RETURN ELECT. #225ETC. (K800933) | R2 Corp. | 1980-05-20 |
Recalls involving this device
No recalls on record reference this clearance.