Penlight/Swab Holder
FDA 510(k) K791001 · Concept, Inc.
510(k) numberK791001
Submission
- Device name
- Penlight/Swab Holder
- Applicant
- Concept, Inc.
Mchenry, IL, US - Received
- May 29, 1979
- Decision date
- June 22, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KYT – Light, Examination, Medical, Battery Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6350
- Specialty
- General Hospital
Other 510(k)s with product code KYT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K920782 | Olympic Trans-LiteKYT · Traditional | Olympic Medical Corp. | 03/27/1992SE |
| K841589 | C-LiteKYT · Traditional | Suncoast Medical Manufacturers, Inc. | 05/22/1984SE |
| K841588 | Sun-Lite White SpotKYT · Traditional | Suncoast Medical Manufacturers, Inc. | 05/22/1984SE |
| K781228 | PenlightsKYT · Traditional | Abco Dealers, Inc. | 09/07/1978SE |
| K760972 | Tycos Diagnostic PenlightKYT · Traditional | Taylor Instrument Analytics Co. | 01/26/1977SE |
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| K896648 | Concept Unicompartmental Knee SystemHSX · Traditional | 06/05/1990SN |
| K894929 | Staple Fixation SystemJDR · Traditional | 08/30/1989SE |
| K892376 | Intravision(Tm) Arthroscope System (Add'L Appli.)HRX · Traditional | 08/01/1989SE |
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| K881954 | Concept Power SystemHSZ · Traditional | 11/09/1988SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | 11/08/1988SE |
| K882121 | C-Flo Suction TubeDXQ · Traditional | 06/20/1988SE |
| K880414 | Tendon HarvesterHRX · Traditional | 03/25/1988SE |
Questions and answers
When was Penlight/Swab Holder cleared by the FDA?
Penlight/Swab Holder (K791001) received a 510(k) decision of Substantially Equivalent on June 22, 1979, 24 days after the submission was received.
What is the product code of K791001?
The FDA product code is KYT – Light, Examination, Medical, Battery Powered, a Class I (low risk) device regulated under 21 CFR 880.6350.