KTZ · Caliper
Orthopedic · 21 CFR 888.4150 · Class 1
Overview
| Product Code | KTZ |
|---|---|
| Device Name | Caliper |
| Regulation | 21 CFR 888.4150 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
Identification
A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Cleared Devices (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K921266 | NK MEDICAL MICROMETER, MODEL MC001 | Nk Biotechnical Engineering Co. | Jul 14, 1992 | SESE |
| K841687 | SKYNDEX ELECTRONIC BODY FAT CALCULA | Caldwell, Justiss & Co., Inc. | Jun 28, 1984 | SESE |
| K831898 | SCOLIMETER | Dr. Micheal A. Sabia | Jul 19, 1983 | SESE |
| K820659 | A CALIPER | Twin City Surgical, Inc. | Mar 19, 1982 | SESE |
| K810116 | ISOROBIC SKINFOLD CALIPER | Fitness Motivation Institute of America | Feb 4, 1981 | SESE |
| K800363 | PARKE-DAVIS TOTAL KNEE PROSTHESIS | Warner-Lambert Co. | Mar 10, 1980 | SESE |
| K760521 | TAPE MEASURE | Mcgaw Laboratories | Nov 12, 1976 | SESE |
Top Applicants
- Warner-Lambert Co. — 1 clearance
- Twin City Surgical, Inc. — 1 clearance
- Nk Biotechnical Engineering Co. — 1 clearance
- Mcgaw Laboratories — 1 clearance
- Fitness Motivation Institute of America — 1 clearance
