Spirabrush CX Biopsy Instrument
FDA 510(k) K011488 · Trylon Corp.
510(k) numberK011488
Submission
- Device name
- Spirabrush CX Biopsy Instrument
- Applicant
- Trylon Corp.
Torrance, CA, US - Received
- May 15, 2001
- Decision date
- February 22, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HFB – Forceps, Biopsy, Gynecological
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944444 | Cit Biopsy PunchesHFB · Traditional | Chirurgische Instrumente | 09/29/1995SE |
| K930773 | Symbiosis Gynecological Biopsy ForcepsHFB · Traditional | Symbiosis Corp. | 07/28/1994SE |
| K933767 | Forceps, Biopsy Gynecological Instru/BiopsyHFB · Traditional | Mahe-Medizintechnik | 05/26/1994SE |
| K926595 | Owens Biopsy ForcepsHFB · Traditional | Owens Industries, Inc. | 05/25/1994SE |
| K926527 | Roto Fit Biopsy ForcepsHFB · Traditional | Thomasville Medical Assoc. | 02/25/1994SE |
| K930036 | Thomas Medical Biopsy ForcepsHFB · Traditional | Thomasville Medical Assoc. | 02/24/1994SE |
| K926538 | Tischler Biopsy ForcepsHFB · Traditional | Thomasville Medical Assoc. | 02/24/1994SE |
| K924224 | Owens Biopsy ForcepsHFB · Traditional | Owens Precision Systems, Inc. | 02/04/1994SE |
| K902049 | Croak Ovarian Biopsy ForcepHFB · Traditional | Gynescope Corp. | 06/07/1990SE |
| K895303 | Ever-Sharp Biopsy ForcepsHFB · Traditional | Southwest Medical Mfg., Inc. | 01/16/1990SE |
More from Southwest Medical Mfg., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033033 | Vizilite-Blue Oral Exam KitEAZ · Traditional | 11/22/2004SE |
| K012070 | Orallite Comprehensive Exam TrayMPU · Traditional | 11/27/2001SE |
| K003995 | Speculite/OralliteEAZ · Traditional | 03/16/2001SE |
| K963391 | SpeculiteMPU · Traditional | 12/12/1997SE |
| K955790 | Pap Plus Speculoscopy Comprehensive Pelvic Exam TrayHIC · Traditional | 03/21/1996SE |
| K953364 | SpeculiteHET · Traditional | 12/08/1995SE |
Questions and answers
When was Spirabrush CX Biopsy Instrument cleared by the FDA?
Spirabrush CX Biopsy Instrument (K011488) received a 510(k) decision of Substantially Equivalent on February 22, 2002, 283 days after the submission was received.
What is the product code of K011488?
The FDA product code is HFB – Forceps, Biopsy, Gynecological, a Class I (low risk) device regulated under 21 CFR 884.4530.