PROXIMATE (TMD) TISSUE MEASURING DEVICE
FDA 510(k) clearance K801374 · decided 1980-06-26
Clearance details
- K-number
- K801374
- Device name
- PROXIMATE (TMD) TISSUE MEASURING DEVICE
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-06-10
- Decision date
- 1980-06-26
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- FTY
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, 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 |
|---|---|---|
| Noxilizer Surgical Ruler (K160501) | Noxilizer, Inc. | 2016-05-26 |
| DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC (K951064) | S-E Sales & Distribution, Inc. | 1995-05-19 |
| OLYMPIC AUTO-LENGTH (K934930) | Olympic Medical Corp. | 1993-12-29 |
| OLYMPIC INFA-LENGTH (K932112) | Olympic Medical Corp. | 1993-07-22 |
| STRYKER PRESSURE MONITOR SYSTEM (K883485) | Stryker Corp. | 1988-09-13 |
| PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S. (K880441) | Plane Iii, Inc. | 1988-02-18 |
| TUMORIMETER (K874352) | Cancer Technologies, Inc. | 1987-11-23 |
| TEMPLATE (K873470) | Cox-Uphuff Intl. | 1987-09-08 |
| LN 100 BREAST MARKER (K872319) | Instrumentation Industries, Inc. | 1987-08-11 |
| KUNDIN WOUND GAUGE (K863409) | Jane I. Kundin | 1986-09-29 |
| PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN) (K862576) | Professional Services For Surgeons, Ltd. | 1986-07-15 |
| PS2 BRAND MAMMAPLASTY (K860912) | Professional Services For Surgeons, Ltd. | 1986-03-24 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ETHIZIA (P240035) | ETHICON, Inc. | 2025-12-15 |
| INTERCEED Absorbable Adhesion Barrier (P880047/S068) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S127) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S122) | ETHICON, Inc. | 2025-11-04 |
| SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126) | ETHICON, Inc. | 2025-10-09 |
| GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067) | ETHICON, Inc. | 2025-10-09 |
| SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125) | ETHICON, Inc. | 2025-09-24 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S066) | ETHICON, Inc. | 2025-09-24 |