HHT · Spatula, Cervical, Cytological
Obstetrics/Gynecology · 21 CFR 884.4530 · Class 2
Overview
| Product Code | HHT |
|---|---|
| Device Name | Spatula, Cervical, Cytological |
| Regulation | 21 CFR 884.4530 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes. (2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant. (3) An umbilical clamp is an instrument used to compress the umbilical cord. (4) A uterine curette is an instrument used to scrape and remove material from the uterus. (5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix. (6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus. (7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination. (8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix. (9) A gynecological cerclage needle is a looplike instrument used to suture the cervix. (10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus. (11) A gynecological fibroid screw is an instrument used to hold onto a fibroid. (12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity. (13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina. (14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures. (15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus. (16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis. (17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina. (18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
Classification Rationale
(1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
Special Controls
*Classification.* (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
Cleared Devices (73)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K182049 | exCellerator Cervical Collection Device | Excell Company, LLC | Apr 25, 2019 | SESE |
| K153128 | Kolplast Cervical Sample Collection Kit | Kolplast CI SA | Jan 13, 2017 | SESE |
| K141057 | DISPOSABLE CERVICAL BRUSH | Ningbo Hls Medical Products Co., Ltd. | May 14, 2015 | SESE |
| K111681 | HISTOBRUSH | Puritan Medical Products Company, LLC | Jan 19, 2012 | SESE |
| K083012 | PAPCONE | Otto Bock Pur Life Science GmbH | Apr 9, 2009 | SESE |
| K081522 | BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY | Bio Nuclear Diagnostics, Inc. | Dec 5, 2008 | SESE |
| K072381 | SOFTPAP CERVICAL CELL COLLECTOR | Cytocore, Inc. | Jan 30, 2008 | SESE |
| K062433 | DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM | Diamics, Inc. | Mar 16, 2007 | SESE |
| K043369 | CERVEX-BRUSH COMBI | Rovers Medical Devices B.V. | Feb 2, 2005 | SESE |
| K042527 | SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 | Medical Action Industries, Inc. | Nov 8, 2004 | SESE |
| K041018 | DRG SOFTRELEASE | Doctor'S Research Group, Inc. | Oct 18, 2004 | SESE |
| K013258 | INPATH E2 COLLECTOR | Molecular Diagnostics | May 31, 2002 | SESE |
| K002520 | ROVERS SPATULA | Rovers Medical Devices B.V. | Nov 13, 2000 | SESE |
| K001119 | ROVERS ENDOCERVEX-BRUSH | Rovers Medical Devices B.V. | May 19, 2000 | SESE |
| K991595 | ORIBRUSH - WITH PROTECTIVE TIP - B001 | Orifice Medical AB | Jun 29, 1999 | SESE |
| K991593 | ORIBRUSH - STANDARD - B002 | Orifice Medical AB | Jun 29, 1999 | SESE |
| K983202 | HARWILL MEDICAL CERVITULA CERVICAL SPATULA | Harwill Medical (Pty) , Ltd. | Mar 15, 1999 | SESE |
| K983599 | SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT | Andwin Scientific | Dec 11, 1998 | SESE |
| K983428 | SAFETEX CERVICAL SCRAPER (PLASTIC) | Andwin Scientific | Nov 16, 1998 | SESE |
| K980356 | CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010 | Canadian Medical Brush, Inc. | Apr 16, 1998 | SESE |
| K971586 | DIGENE CERVICAL BRUSH | Digene Corp. | Sep 19, 1997 | SESE |
| K971849 | CYTOLOGY BRUSH | Team Technologies, Inc. | Jul 24, 1997 | SESE |
| K963801 | PAP BRUSH | Young OU Brush Co. | Apr 9, 1997 | SESE |
| K963685 | EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER | North Eos Industries, Inc. | Oct 11, 1996 | SESE |
| K961934 | PURITAN FOAM TIP SWAB MODEL 2197 | Hardwood Products Co., LP | Jul 9, 1996 | SESE |
| K960469 | DETECT CYTOLOGY BRUSH II | Cook Urological, Inc. | Mar 14, 1996 | SESE |
| K954562 | GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT | Gynetech, Inc. | Dec 22, 1995 | SESE |
| K950780 | AMSINO CERVICAL SCRAPER | Amsino Intl., Inc. | Jul 25, 1995 | SESE |
| K941472 | CERVEX-BRUSH PAP KIT | Rovers Diagnostic Devices | Feb 28, 1995 | SESK |
| K933870 | VIBA-BRUSH | Rovers B.V. | Jan 5, 1995 | SESE |
| K934732 | PELVIC EXAM TRAY | Medcare Custom Packaging, Inc. | Dec 30, 1994 | SESE |
| K942843 | CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY | Rovers Diagnostic Devices | Dec 8, 1994 | SESE |
| K930955 | CERVEX-BRUSH | Rovers B.V. | May 24, 1994 | SESE |
| K912325 | MICRO-PAP(TM) KIT | Micro-Pap Corp. | May 2, 1994 | SESK |
| K933628 | CYTOLOGY BRUSH | Bioteque America, Inc. | Mar 11, 1994 | SESE |
| K933415 | DETECT (TM) CYTOLOGY BRUSH | Cook Ob/Gyn | Feb 25, 1994 | SESE |
| K915844 | EXACT-TOUCH | Baal Assoc., Inc. | Jan 7, 1994 | SESE |
| K911432 | ACCELLON CERVICAL BIOSAMPLER | Medscand AB | Sep 3, 1993 | SESE |
| K923143 | CYTO PAK PAP SMEAR KIT | International Medical Equipment Brokers, Inc. | Jul 16, 1993 | SESK |
| K924908 | CELL COLLECTING BRUSH | Anderson Winn Paper Co. | Apr 13, 1993 | SESK |
| K911327 | CELL SWEEP | Reza S Mohajer, M.D. C/O Krass & Young | May 21, 1991 | SESE |
| K902995 | PC-BEADS POSTCOITAL TEST | Microscopy Research Innovations | Jan 31, 1991 | SESE |
| K902591 | CYTETTE(TM) CYTOLOGY BRUSH | Birchwood Laboratories, Inc. | Sep 10, 1990 | SESE |
| K902589 | CYTOSET(TM) | Birchwood Laboratories, Inc. | Sep 10, 1990 | SESE |
| K893229 | SPATULA FOR PAP SMEAR COLLECTION | Medical Device Inspection Co., Inc. | Feb 22, 1990 | SESE |
| K896065 | WALLACH CC/BRUSH | Wallach Surgical Devices, Inc. | Jan 4, 1990 | SESE |
| K895675 | PAP SMEAR TRAY | Intl. Cytobrush, Inc. | Dec 11, 1989 | SESE |
| K890848 | CERVEX-BRUSH | Unimar, Inc. | May 11, 1989 | SESE |
| K890706 | CYTOBRUSH | Laboratoire Ccd C/O Washington Regulatory Services | Apr 25, 1989 | SESE |
| K890013 | KOTEX SUPER MAXI PADS | Kimberly-Clark Corp. | Apr 25, 1989 | SESE |
| K891032 | ENDO CERVICAL CURETTE - EVANS, RANDALL, GUSBERG | Zinnanti Surgical Instruments, Inc. | Mar 22, 1989 | SESE |
| K890283 | CYTEX ONE AND CYTEX TWO | Anderson Winn Paper Co. | Mar 16, 1989 | SESE |
| K885274 | ROCKET ENDOCERVICAL BRUSH | A & A Medical, Inc. | Mar 9, 1989 | SESE |
| K884873 | CERVICAL BRUSH | Statlab Medical Products, Inc. | Feb 9, 1989 | SESE |
| K884042 | ROCKET CERVICAL SPATULA | A & A Medical, Inc. | Oct 7, 1988 | SESE |
| K882628 | ENDO C BRUSH | Milex Products, Inc. | Jul 25, 1988 | SESE |
| K881921 | C-E BRUSH | Surgipath Medical Industries, Inc. | Jul 19, 1988 | SESE |
| K875162 | ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH | Ortho Diagnostic Systems, Inc. | Jan 27, 1988 | SESE |
| K874604 | HISTOBRUSH | Spectrum Co. | Jan 7, 1988 | SESE |
| K871552 | ORTHO* SPECIMEN COLLECTION CYTOBRUSH | Ortho Diagnostic Systems, Inc. | Jun 26, 1987 | SESE |
| K870782 | CYCLO-BRUSH | Medline Industries, Inc. | May 18, 1987 | SESE |
| K870398 | PAP-PAK CYTOBRUSH KIT | Medical Packaging Corp. | Feb 25, 1987 | SESE |
| K864323 | CYTOLOGY BRUSHES | Medical Packaging Corp. | Jan 9, 1987 | SESE |
| K863145 | CERVICAL SCRAPERS | Surgipath Medical Industries, Inc. | Aug 19, 1986 | SESE |
| K862322 | CHLAMYDIA KIT, STD KIT | Intl. Cytobrush, Inc. | Jul 7, 1986 | SESE |
| K862242 | PAP SMEAR KIT | Quali-Med, Inc. | Jun 26, 1986 | SESE |
| K861389 | PAP SMEAR KIT | Intl. Cytobrush, Inc. | May 2, 1986 | SESE |
| K851934 | CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA | Tridak Division of Indicon, Inc. | Jul 5, 1985 | SESE |
| K850676 | SURGI-PAP KIT | Surgipath Medical Industries, Inc. | Mar 22, 1985 | SESE |
| K832986 | PAP SMEAR BRUSH | Donald G. Zeller | Feb 10, 1984 | SESE |
| K811548 | CERVICAL SPATULA | Procedure Products, Inc. | Jun 23, 1981 | SESE |
| K802139 | SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY | Dyn-A-Med Products | Oct 31, 1980 | SESE |
| K761348 | CERVICAL-VAGINAL SPATULA | Law Offices of Natter & Natter | Jan 18, 1977 | SESE |
Top Applicants
- Surgipath Medical Industries, Inc. — 3 clearances
- Rovers Medical Devices B.V. — 3 clearances
- Intl. Cytobrush, Inc. — 3 clearances
- Rovers Diagnostic Devices — 2 clearances
- Rovers B.V. — 2 clearances
