ENDOCARE ELECTORNIC THERMOMETER SYSTEM
Device Facts
| Record ID | K961365 |
|---|---|
| Device Name | ENDOCARE ELECTORNIC THERMOMETER SYSTEM |
| Applicant | Endocare, Inc. |
| Product Code | FLL · General Hospital |
| Decision Date | Aug 15, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2910 |
| Device Class | Class 2 |
Intended Use
The Endocare Electronic Thermometer System are designed for use in General Surgery, Urology, and Gynecology to monitor tissue temperatures during thermotherapy, cryosurgery, or normal intra operative feedback.
Device Story
Electronic thermometer system; monitors tissue temperature during thermotherapy, cryosurgery, or intra-operative procedures. Inputs: thermocouple probes. Operation: measures temperature via thermocouple sensors; provides real-time feedback to prevent unintended tissue damage. Usage: intra-operative setting; operated by physicians or clinical staff. Output: temperature readings displayed on interface. Benefit: enables precise thermal monitoring to improve safety during surgical interventions.
Clinical Evidence
No clinical data provided; substantial equivalence based on design and performance characteristics compared to predicate devices.
Technological Characteristics
Electronic thermometer system; utilizes thermocouple probes for temperature sensing. Flexible user interface. Sterilization performed by Sterigenics International.
Indications for Use
Indicated for patients undergoing general surgery, urology, or gynecology procedures requiring tissue temperature monitoring during thermotherapy, cryosurgery, or intra-operative feedback.
Regulatory Classification
Identification
A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.
Special Controls
(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
Predicate Devices
- Bailey BAT-8 clinical monitoring thermometers (Pre-Amendment)
- Electromedics TM147T Temperature Monitoring System (K830592A)
Related Devices
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- K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) · Shenzhen Med-Link Electronics Tech Co., Ltd. · Jan 8, 2026
- K072641 — DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4. · Famidoc Technology Co., Ltd. · Nov 1, 2007
- K091676 — MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 · Omron Healthcare, Inc. · Sep 1, 2009
