Inman Medical Packing Strip
FDA 510(k) K921291 · Inman Medical Corp.
510(k) numberK921291
Submission
- Device name
- Inman Medical Packing Strip
- Applicant
- Inman Medical Corp.
Fort Worth, TX, US - Received
- March 11, 1992
- Decision date
- January 21, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FER – Anoscope And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine and perform procedures within the anus and rectum.
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|---|---|---|
| K933171 | Inman Irrigation Tapered ProbeKYZ · Traditional | 04/29/1994SE |
| K933169 | Inman Endoscopic Blunt DissectorGCJ · Traditional | 04/19/1994SE |
| K933094 | Insufflator Tubing Kit W/FilterHIF · Traditional | 04/18/1994SE |
| K933382 | Imc Cable/Wire CoverKKX · Traditional | 01/27/1994SE |
| K933774 | Imc Saline Wet DressingFRO · Traditional | 11/08/1993SN |
| K933306 | Imc 5.0MM Irrigation/Aspiration Probe W/HolesGCY · Traditional | 10/05/1993SE |
| K933305 | Imc 5.0MM Irrigation/Aspiration ProbeGCY · Traditional | 10/05/1993SE |
| K933170 | Inman Poole Tip Suction Probe W/Tubing KitGCY · Traditional | 09/16/1993SE |
| K932762 | 10.0MM Suction/Irrigation Probe & Tubing KitGCS · Traditional | 08/31/1993SE |
| K933371 | Imc Endoscopic Instrument HolderGCS · Traditional | 08/06/1993SE |
Questions and answers
When was Inman Medical Packing Strip cleared by the FDA?
Inman Medical Packing Strip (K921291) received a 510(k) decision of Substantially Equivalent on January 21, 1993, 316 days after the submission was received.
What is the product code of K921291?
The FDA product code is FER – Anoscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.