Panels › Obstetrics/Gynecology › Product code HHT · Class 2
Spatula, Cervical, Cytological
Regulation 884.4530
0510(k)s in 12 months (73 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HHT
| Company | 510(k)s | Recalls |
|---|---|---|
| Intl. Cytobrush, Inc. | 3 | 0 |
| Rovers Medical Devices B.V. | 3 | 0 |
| Surgipath Medical Industries, Inc. | 3 | 0 |
| A & A Medical, Inc. | 2 | 0 |
| Anderson Winn Paper Co. | 2 | 0 |
| Andwin Scientific | 2 | 0 |
| Birchwood Laboratories, Inc. | 2 | 0 |
| Medical Packaging Corp. | 2 | 0 |
| Orifice Medical AB | 2 | 0 |
| Ortho Diagnostic Systems, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 25, 2019 | K182049 | exCellerator Cervical Collection Device Excell Company, LLC | HHT |
| Jan 13, 2017 | K153128 | Kolplast Cervical Sample Collection Kit Kolplast CI SA, BR | HHT |
| May 14, 2015 | K141057 | DISPOSABLE CERVICAL BRUSH Ningbo Hls Medical Products Co., Ltd. | HHT |
| Jan 19, 2012 | K111681 | HISTOBRUSH Puritan Medical Products Company, LLC | HHT |
| Apr 9, 2009 | K083012 | PAPCONE Otto Bock Pur Life Science GmbH, DE | HHT |
| Dec 5, 2008 | K081522 | BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY Bio Nuclear Diagnostics, Inc., CA | HHT |
| Jan 30, 2008 | K072381 | SOFTPAP CERVICAL CELL COLLECTOR Cytocore, Inc. | HHT |
| Mar 16, 2007 | K062433 | DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM Diamics, Inc. | HHT |
| Feb 2, 2005 | K043369 | CERVEX-BRUSH COMBI Rovers Medical Devices B.V., NL | HHT |
| Nov 8, 2004 | K042527 | SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 Medical Action Industries, Inc. | HHT |
| Oct 18, 2004 | K041018 | DRG SOFTRELEASE Doctor'S Research Group, Inc. | HHT |
| May 31, 2002 | K013258 | INPATH E2 COLLECTOR Molecular Diagnostics | HHT |
| Nov 13, 2000 | K002520 | ROVERS SPATULA Rovers Medical Devices B.V. | HHT |
| May 19, 2000 | K001119 | ROVERS ENDOCERVEX-BRUSH Rovers Medical Devices B.V. | HHT |
| Jun 29, 1999 | K991595 | ORIBRUSH - WITH PROTECTIVE TIP - B001 Orifice Medical AB, SE | HHT |
| Jun 29, 1999 | K991593 | ORIBRUSH - STANDARD - B002 Orifice Medical AB, SE | HHT |
| Mar 15, 1999 | K983202 | HARWILL MEDICAL CERVITULA CERVICAL SPATULA Harwill Medical (Pty) , Ltd. | HHT |
| Dec 11, 1998 | K983599 | SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT Andwin Scientific | HHT |
| Nov 16, 1998 | K983428 | SAFETEX CERVICAL SCRAPER (PLASTIC) Andwin Scientific | HHT |
| Apr 16, 1998 | K980356 | CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010 Canadian Medical Brush, Inc., CA | HHT |
| Sep 19, 1997 | K971586 | DIGENE CERVICAL BRUSH Digene Corp. | HHT |
| Jul 24, 1997 | K971849 | CYTOLOGY BRUSH Team Technologies, Inc. | HHT |
| Apr 9, 1997 | K963801 | PAP BRUSH Young OU Brush Co., KR | HHT |
| Oct 11, 1996 | K963685 | EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER North Eos Industries, Inc., TW | HHT |
| Jul 9, 1996 | K961934 | PURITAN FOAM TIP SWAB MODEL 2197 Hardwood Products Co., LP | HHT |
| Mar 14, 1996 | K960469 | DETECT CYTOLOGY BRUSH II Cook Urological, Inc. | HHT |
| Dec 22, 1995 | K954562 | GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT Gynetech, Inc. | HHT |
| Jul 25, 1995 | K950780 | AMSINO CERVICAL SCRAPER Amsino Intl., Inc. | HHT |
| Feb 28, 1995 | K941472 | CERVEX-BRUSH PAP KIT Rovers Diagnostic Devices | HHT |
| Jan 5, 1995 | K933870 | VIBA-BRUSH Rovers B.V. | HHT |
| Dec 30, 1994 | K934732 | PELVIC EXAM TRAY Medcare Custom Packaging, Inc. | HHT |
| Dec 8, 1994 | K942843 | CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY Rovers Diagnostic Devices | HHT |
| May 24, 1994 | K930955 | CERVEX-BRUSH Rovers B.V. | HHT |
| May 2, 1994 | K912325 | MICRO-PAP(TM) KIT Micro-Pap Corp. | HHT |
| Mar 11, 1994 | K933628 | CYTOLOGY BRUSH Bioteque America, Inc. | HHT |
| Feb 25, 1994 | K933415 | DETECT (TM) CYTOLOGY BRUSH Cook Ob/Gyn | HHT |
| Jan 7, 1994 | K915844 | EXACT-TOUCH Baal Assoc., Inc. | HHT |
| Sep 3, 1993 | K911432 | ACCELLON CERVICAL BIOSAMPLER Medscand AB, SE | HHT |
| Jul 16, 1993 | K923143 | CYTO PAK PAP SMEAR KIT International Medical Equipment Brokers, Inc. | HHT |
| Apr 13, 1993 | K924908 | CELL COLLECTING BRUSH Anderson Winn Paper Co. | HHT |
| May 21, 1991 | K911327 | CELL SWEEP Reza S Mohajer, M.D. C/O Krass & Young | HHT |
| Jan 31, 1991 | K902995 | PC-BEADS POSTCOITAL TEST Microscopy Research Innovations | HHT |
| Sep 10, 1990 | K902591 | CYTETTE(TM) CYTOLOGY BRUSH Birchwood Laboratories, Inc. | HHT |
| Sep 10, 1990 | K902589 | CYTOSET(TM) Birchwood Laboratories, Inc. | HHT |
| Feb 22, 1990 | K893229 | SPATULA FOR PAP SMEAR COLLECTION Medical Device Inspection Co., Inc. | HHT |
| Jan 4, 1990 | K896065 | WALLACH CC/BRUSH Wallach Surgical Devices, Inc. | HHT |
| Dec 11, 1989 | K895675 | PAP SMEAR TRAY Intl. Cytobrush, Inc. | HHT |
| May 11, 1989 | K890848 | CERVEX-BRUSH Unimar, Inc. | HHT |
| Apr 25, 1989 | K890706 | CYTOBRUSH Laboratoire Ccd C/O Washington Regulatory Services | HHT |
| Apr 25, 1989 | K890013 | KOTEX SUPER MAXI PADS Kimberly-Clark Corp. | HHT |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.